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The American Journal of Hematology/Oncology (AJHO) in their review article states about the trials conducted on Adjuvant chemotherapy and radiation following PDD for pancreatic adenocarcinoma, whereby following given were the inferences.

Pancreatic cancer is the ninth most common malignancy as it remains the fourth leading cause of cancer deaths in the United States because the majority of patients present with advanced disease at diagnosis. For the approximately 20% of patients who present with potentially resectable disease, the standard of care and only potentially curative treatment is complete resection of the tumor. However, given the high likelihood for both locoregional and distant failure following resection, several studies have investigated the use of adjuvant therapies. Adjuvant chemoradiation for pancreatic cancer: A summary of conflicting studies One of the initial studies attempting to address the utility of adjuvant therapy was a prospective phase III trial initiated by the Gastrointestinal Tumor Study Group (GITSG) in which patients were treated with curative resection followed by randomization to either observation or 500 mg/m² 5-fluorouracil (5-FU)-based radiation (40 Gy in a 6-week split course) followed by weekly 5-FU for 2 years.

Another study attempting to address the utility of adjuvant CRT was a prospective, non randomized trial conducted from 1991 to 1995 within our institution by Yeo and colleagues. Following surgical resection, patients were able to choose between continued observation (n=53) or radiation therapy with concurrent and maintenance bolus 5-FU either with (n=99) or without (n=21) prophylactic liver irradiation. Radiation therapy was delivered in a split course similar to that in the GITSG study.³ Those receiving adjuvant therapy had a significantly better median (19 vs 13.5 months) and 2-year overall survival (40% vs 31%) compared with the observation arm. Whereas these results supported the use of adjuvant CRT, the study groups were not directly comparable due to differences in age and postoperative complications.

After controlling for high-risk features (tumor size >3 cm, high grade, margin-positive disease, postoperative complications, and age), the use of CRT was associated with a statistically significant improved median survival, thereby supporting its use in the adjuvant setting. Similar to our study, Corsini and colleagues published a 30-year retrospective analysis of the Mayo Clinic experience in which they found a statistically significant improvement in median and 5-year overall survival with CRT compared with observation following an R0 resection.

The European Study Group for Pancreatic Cancer (ESPAC) conducted a phase III randomized trial of 541 patients.¹¹ Unfortunately, the results of this relatively large study were confounded by the complex study design and poor quality assurance. Following PDD, patients were stratified by a double-randomized, 2 × 2 factorial design to receive chemotherapy alone, CRT, CRT followed by chemotherapy, or observation. The CRT was 5-FU–based bolus with split-course radiation, similar to the GITSG study.³ centralized radiation quality assurance, allowance for physician selection bias, and previous background therapy. Indeed, Oettle and colleagues suggest that these results not be overinterpreted given the inadequate power of the study to determine the statistical and clinical significance of its findings.

Source: The American Journal of Hematology/Oncology